Cambridge-based Biogen got a signal that Europe’s medicines regulator may be reluctant to clear its controversial Alzheimer’s disease drug.
A panel of the European Medicines Agency gave “a negative trend vote” on the U.S. drugmaker’s application, the company said Wednesday. A formal decision could come at the group’s next meeting in mid-December. The stock dropped 3.5% in trading before U.S. exchanges opened.
The drug, Aduhelm, has already faced controversy in the U.S. as expert advisers to the Food and Drug Administration question whether the medicine really works, even though the agency has approved it. Meanwhile, patient groups have cheered the arrival of the first therapy that aims to alter the course of the brain disorder.
A rejection in the European Union “effectively wipes away 40% of potential future revenue,” Brian Abrahams and other analysts at RBC Capital Markets wrote in a note to clients.
Biogen said it will engage with the EMA and the panel.
“While we are disappointed with the trend vote, we strongly believe in the strength of our data,” said Priya Singhal, the company’s interim head of research and development, in a statement. The medicine “has the potential to make a positive and meaningful difference.”
The drugmaker conducted two large trials of the drug’s effect on patients with mild cognitive impairment that yielded conflicting results. The FDA’s June clearance sparked uproar, as some members of the outside committee that advised regulators resigned in protest.
Uptake has been slow in the U.S. as private health insurers and government programs weigh whether to pay for the drug. Some doctors said the benefits, if they exist, aren’t clinically meaningful and don’t outweigh potential side effects including brain swelling.
A negative EU decision may influence sentiment on other companies working on experimental Alzheimer’s treatments, including Roche Holding AG.